Repro Support Medi · 89-08 · JAPAN
For Repro Support Medi, import alert is 89-08; country is JAPAN; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Vitrification Kits; product code is 85 M - - QK Labware, Assisted Reproduction; date published is 06/15/2016; address is 2-5-5 8f Shinjuku , Tokyo, JAPAN, verified against its source on 2026-09-30.
- Firm
- Repro Support Medi verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- JAPAN verified
- Address
- 2-5-5 8f Shinjuku , Tokyo, JAPAN verified
- Date published
- 06/15/2016 verified
- Product code
- 85 M - - QK Labware, Assisted Reproduction verified
- Product
- Vitrification Kits verified
What the source says
Repro Support Medi Date Published : 06/15/2016 2-5-5 8f Shinjuku , Tokyo, JAPAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
85 M - - QK Labware, Assisted Reproduction Date Published: 06/15/2016 Desc: Vitrification Kits
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.